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New Role for QA Managers in Bioterrorism Act Compliance
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"Recipe management enables the manufacturer to conduct nutritional and laboratory analysis with recipe revisions. Again, a valid and useful function for food ERP software, yet not specific to compliance with the Bioterrorism Act," says Rory Job, Vice President of BatchMaster Software, Inc.
"We have done a heap of work to significantly expand lot traceability, specifically for the Bioterrorism issues. However, I'm not sure that the (Bioterrorism) Act allows an ERP system to make you compliant… it's all about processes and people, with your system helping but by itself it does not make you compliant," says Michael Panosh, Chief Executive Officer of PRONTO North America, a management software developer.
Non-ERP Platforms
Vigilistics, Inc.'s platform is not an ERP system. It is software designed to provide the records needed for compliance under the US Bioterrorism Act and for FDA regulations. It also provides records on energy use, product loss and production data for ERP systems. Most food processing companies still rely on the manual data entry of production results and ingredient usage, despite massive investments in ERP systems. The Vigilistics platform collects accurate and auditable production data in a template form.
ToolWorx Information Products Inc., a systems integrator specializing in automatic identification applications for part traceability and error proofing has developed a Lot Track system that keeps track of all of the data required by the FDA. Additionally, the food traceability system allows tracking of which finished items have already shipped and which items are still in the manufacturing facility to quarantine any potentially contaminated containers prior to shipment.
 QA Manager – Integral Decision Influencers
As varied as the ERP vendors (and other data collection software technology providers) are in responding to the compliance requirements of the Bioterrorism Act, so is the role of the QA Manager in technology selection.
"If we were selecting a new ERP system today, I am confident that I would be much more involved in the decision-making process due to the Bioterrorism Act requirements." Less than 10 percent of QA Managers were significantly involved in the selection of the current ERP system," says Lucia Falek, QA Manager for Butterball Farms, Inc.
After food manufacturers have invested heavily in ERP systems there is a demand, or certainly an expectation, that the ERP vendor must be part of the solution in Bioterrorism Act compliance. Striking a balance between effective ERP integration and tools for Bioterrorism Act and other regulatory requirements is not easy. Finding a balance between food manufacturing sector idiosyncrasies and a solid ERP system is challenging.
The basic ERP functions are often lacking when the focus is too heavily on the bells and whistles of the industry sector.
 "Many vertical ERP applications in the food sector lack strong financials and must integrate with bolt-on third party systems," TGI's Rebecca says. Often these ad hoc, bolt-on solutions are antithetical to the whole notion of an integrated ERP system.
The biggest impact of the Bioterrorism Act may be the recognition of the decision-influencing role of the QA Manager in technology selection; likewise ERP and other technology vendors may start to market to this audience because regulatory requirements mandate the QA Managers' role in compliance and data collection and reporting.
Thomas R. Cutler is President and CEO of TR Cutler, Inc., one of the largest manufacturing marketing firms worldwide. He is founder of the Manufacturing Media Consortium of 2700 journalists and editors writing about trends in manufacturing. Thomas is the lead spokesperson for the ETO Institute and also the author of the Manufacturer's Public Relations and Media Guide. He is a frequently published author within the manufacturing sector with more than 300 feature articles authored annually. For article feedback, contact Thomas at trcutler@trcutlerinc.com
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